An open-label, pilot study to assess the effectiveness and safety of hyaluronic acid gel in the restoration of soft tissue fullness of the lips.

[BACKGROUND] There have been few systematic investigations of the effectiveness, safety and tolerability of aesthetic lip augmentation using hyaluronic acid (HA) fillers.

[OBJECTIVES] Evaluate the effectiveness of small gel particle hyaluronic acid filler (Restylane Injectable Gel [SGP-HA]; Medicis Aesthetics Inc., Scottsdale, AZ) in lip augmentation using the Medicis Lip Fullness Scale (MLFS). Assess subjective improvement in lip appearance using the Global Aesthetic Improvement Scale (GAIS).

[PATIENTS, MATERIALS AND METHODS] Investigators treated 21 adults. The primary efficacy endpoint was an increase in lip fullness at least one grade on MLFS at eight weeks post-treatment. Adverse events were reported using patient diaries.

[RESULTS] Sixteen of 18 evaluable subjects (89%) had an improvement at least one grade on MLFS in both lips. MLFS and GAIS scores were consistent, suggesting clinically significant aesthetic improvement. Adverse effects were transient and mostly mild to moderate in severity.

[CONCLUSION] Lip augmentation with SGP-HA was well tolerated and resulted in clinically meaningful increases in lip fullness.